The Methodology And Reporting Quality Research Of The Clinical Study In The Field Of Traditional Chinese Medicine

Background With the increasing of research funding from Nation in the field of TCM, the number of its scientific papers is quickly increasing as well.Moreover, with the development of the concept of evidence-based medicine, the researchers recognize that the scientific quality of research and the utilization and conversion of those research results is the key. However, some problems in the methods of design and reporting quality reduced the reliability of the clinical trisls. So, it is necessary to systematic review all the factors involved the Chinese medicine clinical research design, implementation and reporting that might affect their study quality, and find the important specific differences compared with the same field studies carried out in foreign countries in order to improve the quality of Chinese clinical trials.Objective Investigating the status of methodology and reporting quality of in the research field of traditional Chinese medicine and randomized controlled trials and provided the policy advices to improve the quality of clinical trials of traditional Chinese medicine.Methods1.To assess the quality of SRs/Meta-analysis of TCM intervention published in Chinese journals base on the AMSTAR and PRISMA checklist by bibliometrics.2.To compare the quality of domestic and foreign SRs/Meta-analysis of acupuncture intervention:A comparative study.3. To compare the quality RCTs of acupuncture intervention published in Chinese journals based on the different periods of checklists were introduced into China:A retrospective study.4. Endorsement of the different clinical trials reporting checklist by Chinese TCM journals:a survey of journal editors and journal. The SPSS18.0software was used for data analysis.Results1.A total number of369SRs/Meta-analysis of TCM intervention published in Chinese journals was included, which showed that the methodology and reporting quality was poor. The important problems included the following context:①Retrieval searching method was not comprehensive(45%,203/369);②Not included different publish paper(97.3%,359/369);③Not provided excluding paper checklist(96.5%,356/369);④The inclusion criteria was broad not specific(42%,155/369);⑤Without using the double independent mechanism to select the literature and extract data(58.8%,217/369);⑥Without detailed description the process of included and excluded literature(55%,203/369);⑦The method merging data was not appropriate(70.7%,261/369). In addition, only half clinician take part in the research, the citation of nearly half paper was zero.2. A total number of366SRs/Meta-analysis of acupuncture intervention were included, including88Chinese SRs,226Other SRs and52Cochrane SRs. The proportion of coincidence more than80%of three different types of SRs in AMSTAR and PRISMA checklist were45%(Chinses SRs).vs73%(Other SRs).vs91%(Ccohrane SRs) and59%(Chinses SRs).vs74%(Other SRs).vs78%(Ccohrane SRs), respectively. Compared with Other SRs and Cochrane SRs, there were many defect in Chinese SRs. Such as, included different published paper(2%.vs91%.vs100%), comprehensive retrieval searching(40%.vs87%.vs100%), conflict of interest(0%.vs61%.vs100%), evidence synthesis results(23%.vs99%.vs96%), protocol and register information(0%.vs4%.vs100%).3. A total number of1978RCTs of acupuncture intervention published in Chinese journals were included. The quality of reporting in several important methodological components, including sample size calculation (0%vs.0%vs.1.2%), randomization sequence generation (1.4%vs.15%vs.26.3%) and implementation(0%vs.0%vs.1.3%), allocation concealment (0%vs.1.4%vs.4.9%), blinding (0%vs.5.7%vs.9.1%), has not improved. In addition, there were many defect in description of acupuncture intervention. Such as, the specific types of acupuncture therapy(6.6%.vs9.9%.vs12.7%);②reasons and basis of acupuncture therapy(0%.vs0.3%.vs1.0%);③subjects objects of each treatment unit number of needles used(0%.vs0.3%. vs0.2%);④describe other interventions(19.7%.vs30.1%.vs33.7%);⑤The acupuncturist qualification(0%.vs0%.vs0.4%).4. A total number of63journals were included, which two journals were cited by SCI, eight journals were cited by Medline/Embase, seven journals were cited by CSCD. Only three journals require author to report RCTs based on CONSORT Statement,and gave the version and website link meanwhile. No journal mentioned the PRISMA, MOOSE, TREND, STARD and STROBE checklist so far. Besides, we surveyed sixty-three ditorial staffs of Chinese journal of TCM by E-mail and Telephone, fifty-four journals gave back. The feedback rate was85.7%, thirty-nine were editor, three were chief editor, nine were director. Of the eleven editors known the CONSORT Statement, three editors just heard and did not understand it at all. Out of three editors of fifty-four said that they required the author to report the RCT based on CONSORT Statement. And twenty five (46%) editors think that it was unnecessary to introduce it in its "Instruction to Authors" in the future. As for PRISMA checklist, only two editors understood it and seven editors just heard. They said that they did not require the author to report the SRs/Meta-analysis based on PRISMA checklist. Thirty-five (65%) editors think that it was unnecessary to introduce PRISMA checklist in its "Instruction to Authors". In addition, there was no any editor known the MOOSE, TREND, STARD, STROBE checklists.Conclusion The quality of clinical study is the key factor to affect the transformation and utilization, only high quality clinical research to provide a reliable scientific basis for clinical practice. Even though the coincidence of reporting quality of TCM intervention in Title, Abstract, included study characteristic were well, the key factors that may impact the quality were still poor. As for the number of RCTs after published in2003were quickly increased, the coincidence in many items were still poor, and the reporting quality of RCTs of acupuncture intervention was not improved with the STRICTA checklist was introduced into China. In addition, the endorsement of clinical study reporting statement in "Instruction to Authors" of journals of traditional Chinese medicine (TCM) was worried. The reason might be that the standard for reports of medical research in China is not a mandatory requirement. We propose to improve the quality of clinical research quality through the following measures:①Endorsement of the different clinical trials reporting checklist into Chinese TCM journal to improve the quality of clinical study;②Encouraging author, editor and peer review to abide the clinical study reporting;③Carried out the training of knowledge about the reporting quality for editors;④Carried out the training of knowledge about SRs and Meta-analysis for clinician, researcher;⑤The clinical research report and related knowledge included into the school education.